Links Between Epileptic Activity, Sleep Disruption and Mental Content During Sleep
报名条件(概要)
- 年龄:18 Years – 55 Years
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
United States、France
药品与企业信息
1. DES will be first performed during wake as part of routine SEEG evaluation. Bipolar stimulations of adjacent contacts will be applied using biphasic square wave pulses at low frequency and at high frequency. Intensity will be increased stepwise by increments of 0.5mA until the appearance of an objective or a subjective symptom or after-discharges or seizure. 2. Stimulations will be repeated in rapid eye movement (REM) and non REM sleep during the first two cycles of a single night with simultaneous polysomnography (PSG) recording. Stimulation will involve channels from the seizure onset zone and channels outside de seizure onset zone. If the patient wakes up following stimulations, they will be asked what was going through their mind and how deep was their sleep before awakening. If no awakening occurs but an after-discharge or a seizure is provoked, the patient will be awoken (with a maximum of 6 awakenings in REM and 6 in NREM) and also asked about sleep depth and dream content.
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
Interactions between epilepsy and sleep are numerous and bidirectional. Sleep can facilitate epileptic activity and seizures in several syndromes, while sleep deprivation increases cortical excitability and seizure susceptibility. Conversely, sleep disturbances are highly prevalent in patients with epilepsy (PWE). Using simultaneous stereoelectroencephalography (SEEG)-polysomnography, the investigators previously showed that sleep fragmentation in focal drug-resistant epilepsy is associated with both ictal and interictal epileptic activity, with increased interictal epileptiform discharges (IED) immediately before and during arousals. However, causality remains unclear, as sleep instability itself may promote epileptic discharges. Determining whether nocturnal seizures and IED directly induce awakenings is clinically important. Nocturnal epileptic activity is often considered less disabling than daytime seizures and rarely guides treatment decisions, yet demonstrating a direct impact on sleep continuity could support therapeutic strategies specifically targeting nocturnal epileptic activity to improve sleep quality. Beyond sleep continuity, epilepsy may also influence cognitive processes during sleep, including subjective sleep depth and dreaming. While the cognitive consequences of epilepsy during wakefulness are well established, relationships between epileptic activity, sleep architecture and subjective sleep experiences remain poorly understood. In a survey of 300 PWE, the investigators observed altered dream recall frequency and dream content, with seizure-related dreams associated with nocturnal seizures. However, retrospective morning reports cannot establish temporal relationships between epileptic discharges and dream phenomena, nor determine the influence of discharge localization or sleep stage. SEEG combined with direct electrical stimulation (DES) provides a unique framework to address these questions. DES is routinely used during presurgical evaluation to identify epileptogenic and eloquent cortex, but is mainly performed during wakefulness. Yet sleep modifies functional connectivity and facilitates epileptic activity, suggesting that DES during sleep may increase the sensitivity of stimulation-based localization of the seizure-onset zone. The EPIDREAM 3 study will investigate whether DES-induced epileptic activity during sleep provokes arousals, alters dream recall or content, and modifies perceived sleep depth. It will also assess whether sleep-related DES improves delineation of epileptogenic networks, particularly in sleep-related epilepsies. Detailed description: Patients with frontal or temporal drug-resistant focal epilepsy investigated with SEEG as part of presurgical evaluation will be included in the Department of Functional Neurology and Epileptology of the HCL, Lyon. The investigators will use intra-cranial DES performed during the SEEG investigation to explore the impact of focal induced epileptic activity on arousal and dreams. 1. DES will be first performed during wake as part of routine SEEG evaluation with the double purpose of localizing the seizure onset zone and providing a functional mapping. This step identifies channels: (i) in the assumed SOZ, where DES induces after-discharges with/without seizure symptoms; (ii) in the assumed SOZ, where DES induces no after-discharge/seizure but may induce clinical symptoms; (iii) in non-epileptic areas, where stimulation induces neither. For temporal lobe epilepsy, control channels will be selected in the frontal lobe; for frontal lobe epilepsy, in the temporal lobe 2. Stimulations will be repeated in REM and NREM sleep (N2/N3) during the first two sleep cycles of a single night with simultaneous PSG. The investigators will assess for each stimulation: (1) the precise location of the channel (2) the presence and characteristics of an induced after-discharge or seizure (3) presence of a spontaneous arousal (3-15 sec) or awakening (\> 15 sec) (4) presence of objective symptoms (5) in case of awakening: presence of subjective reported symptoms, sleep depth and mind content
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人(申办方/研究总部)
- PETER-DEREX MD Laure, MDlaure.peter-derex@chu-lyon.fr+33 (0) 4 72 35 70 44
研究中心联系方式
- Epilepsy Department, Duke University HospitalDurham,North Carolina,United States
- Service de Neurologie Fonctionnelle et d'Epileptologie Hôpital Neurologique, GHE, Hospices Civils de Lyon Hôpital Neurologique Pierre WERTHEIMERBron,France
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Links Between Epileptic Activity, Sleep Disruption and Mental Content During Sleep ClinicalTrials.gov Identifier: NCT07605858 Sponsor: Hospices Civils de Lyon Investigational product: Direct Electric Stimulation (DES) About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:Links Between Epileptic Activity, Sleep Disruption and Mental Content During Sleep 试验编号:NCT07605858 申办方:Hospices Civils de Lyon 研究药物:Direct Electric Stimulation (DES) 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。